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Quality control method of corydalis tuber analgesic capsule

A quality control method, Yuanhu pain-relieving technology, applied in the directions of non-central pain relievers, medical preparations containing active ingredients, measuring devices, etc., can solve the problem that the content of active ingredients cannot be guaranteed, etc.

Inactive Publication Date: 2009-07-29
SICHUAN MEDCO PHARML
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Problems solved by technology

[0004] In the original quality control method, the quality standard of Yuanhu Zhitong Capsules only includes the routine inspection items of the capsules, only for qualitative identification of medicinal materials, without content determination indicators, and the content of active ingredients in the capsules cannot be guaranteed. In order to ensure the proper clinical efficacy of the drug, It is Necessary to Quantitatively Test the Active Ingredients in Yuanhuzhitong Capsules

Method used

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  • Quality control method of corydalis tuber analgesic capsule
  • Quality control method of corydalis tuber analgesic capsule
  • Quality control method of corydalis tuber analgesic capsule

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Embodiment 1

[0067] In this embodiment, 6 batches of Yuanhu Zhitong Capsules (batch numbers: 020301, 020302, 020304, 020305, 020306, all provided by Sichuan Medakang Pharmaceutical Co., Ltd.) are used to measure the content of tetrahydropalmatine by the method of the present invention. The specific method as follows:

[0068] (1) Take the contents of 10 capsules of Yuanhu Zhitong Capsules, grind them finely, put them in a Soxhlet extractor, add 100mL of methanol, heat and reflux until the extract is colorless, evaporate the extract to dryness, add 10% acetic acid solution to the residue and divide twice Dissolve, filter, add concentrated ammonia solution to the filtrate to adjust the pH value to 8-9, extract four times with ether (25, 25, 20, 20mL), combine the ether solution, evaporate to dryness, add 1mL methanol to the residue to dissolve, and use it as the test product solution. Another 1 g of Corydalis Corydalis reference medicinal material was taken, and the same as above was prepar...

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Abstract

The invention relates to a method for controlling the quality of a corydalis tuber paregoric capsule and belongs to the technical field of quality control of drug preparations. The method for controlling the quality of the corydalis tuber paregoric capsule is based on character identification of the prior capsule drug material, adopts a thin layer chromatography method to carry out content mensuration on tetrahydropalmatine, precisely extracts solutions of a test sample and a reference substance, drops the solutions on the same silica gel G plate and uses n-hexane-acetic ether-ammonia (6:4:0.2, volume ratio) as a developing agent; the drops are developed, colored, taken out and scanned by the chromatography method; the wavelength lambda s is equal to 345 nm; and lambda R is equal to 307 nm; and the integral quantity of absorbance of the test sample and the absorbance of the reference substance are measured and calculated to obtain the content of the tetrahydropalmatine in a content of the corydalis tuber paregoric capsule. The method for the quality control has simple operation, an accurate result, precision, stability and good repeatability so as to accurately and effectively control the quality of the corydalis tuber paregoric capsule, so the method is favorable for ensuring the exertion of clinical treatment effect.

Description

technical field [0001] The invention relates to a quality control method of Yuanhuzhitong capsules, belonging to the technical field of quality control of pharmaceutical preparations. Background technique [0002] Yuanhu Zhitong Capsules are recorded in Volume 8 of "Ministry of Health Drug Standards for Traditional Chinese Medicine Prescriptions", and are composed of Yuanhu and Angelica dahurica. In the prescription, Yuanhu is the king medicine. Yuanhu, also known as Yanhusuo, is the dry tuber of Yuanhu, a plant of the genus Corydalis in the family Papaveraceae. It is a good medicine for pain relief and antispasmodic. This medicine is made with vinegar to enhance the pain relief effect. Modern studies have proved that 15 kinds of alkaloids can be isolated from Yuanhu, among which corydrine A, B, ugine, and decane all have analgesic effects. Pharmacological experiments show that the analgesic effect of tetrahydropalmatine is the strongest, and the content of tetrahydropalma...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/66A61P25/04A61P29/00G01N30/90
Inventor 李彦钟昌珍
Owner SICHUAN MEDCO PHARML
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